Trial record 1 of 1731 for:    Back Pain
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Internet App to Self-Manage Occasional Low Back Pain (BackPain2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
A. Blair Irvine, Oregon Center for Applied Science, Inc.
ClinicalTrials.gov Identifier:
NCT01950091
First received: September 11, 2013
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

Nonspecific low back pain (NLBP) is the diagnosis for 85% of low back pain sufferers with no underlying medical cause (e.g., herniated disc, spinal stenosis) that requires physician care. Treatment, however, is impractical for many physicians to implement during office visits, and there are relatively few providers for NLBP treatment that follow national pain control guidelines. This study evaluated the efficacy of an on-line intervention using desktop computers or mobile technology to help users self treat NLBP occurrences and to engage in activities to decrease future occurences.


Condition Intervention
Low Back Pain
Behavioral: FitBack on-line intervention
Other: Alternative Website Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Internet App to Self-Manage Occasional Low Back Pain

Resource links provided by NLM:


Further study details as provided by Oregon Center for Applied Science, Inc.:

Primary Outcome Measures:
  • Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Back pain history: intensity, frequency, duration


Secondary Outcome Measures:
  • Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures [ Time Frame: baseline, 2 and 4 months ] [ Designated as safety issue: No ]
    Internally developed rating scales


Enrollment: 606
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FitBack on-line intervention
On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
Behavioral: FitBack on-line intervention
On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
Other Name: Fitback app
Active Comparator: Alternative website control
Intervention is a Menu of links to 4 popular Websites offering back pain education
Other: Alternative Website Control
Intervention is a Menu of links to 4 popular Websites offering back pain education
No Intervention: Usual care control group
No contact; Control group

Detailed Description:

Methods. A total of 606 adults, 18 years of age and older were recruited, screened, and consented online. They were assessed on-line at baseline, at two months weeks, and at four months After the baseline assessments, participants were randomized into NLBP treatment (TX), alternative website control (AWC), and no-contact control groups. The TX and AWC groups received 8 weekly emails prompt to visit their respective experimental websites.

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  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • suffered low back pain in previous 3 months
  • employed or family of employee

Exclusion Criteria:

  • on-going medical care for low back pain
  • positive response to questions about symptoms which medically disqualify potential participant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950091

Sponsors and Collaborators
Oregon Center for Applied Science, Inc.
Investigators
Principal Investigator: Blair Irvine, PhD ORCAS Research Scientist
  More Information

No publications provided

Responsible Party: A. Blair Irvine, Research Scientist, Oregon Center for Applied Science, Inc.
ClinicalTrials.gov Identifier: NCT01950091     History of Changes
Other Study ID Numbers: Back Pain II Study, R44AR054652
Study First Received: September 11, 2013
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Oregon Center for Applied Science, Inc.:
low back pain
internet
app
prevention
treatment

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014